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February 06, 2012
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Drug Litigation News

 

Stronger Warnings For Tequin

Bristol-Myers Squibb Co. announced labeling changes for Tequin (gatifloxacin), an antibiotic indicated for the treatment of patients with pneumonia, bronchitis, uncomplicated gonorrhea, and various infections including infections of urinary tract, kidneys, and skin.

The labeling changes, announced by the Tequin manufacturer in a letter to healthcare professionals, update the prescription information as a result of continued reports of serious cases of hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar) in patients receiving Tequin. Since the approval of Tequin in 1999, there have been rare cases of life-threatening events reported globally in patients treated with the drug. Most of these events were reversible when properly managed, but a few had fatal outcomes.

Information about the risks of low blood sugar and high blood sugar was added to the WARNINGS section of the U.S. labeling in 2002. Today's changes strengthen the existing WARNING on hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar), add a CONTRAINDICATION for use in diabetic patients, and include information identifying other risk factors for developing low blood sugar and high blood sugar, including advanced age, renal insufficiency, and concomitant glucose altering medications while taking Tequin. The FDA will continue monitoring Tequin's safety to ensure that its benefits outweigh the risks to patients.

 

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Did You Know?    
 
 
Many over the counter drugs were once prescription drugs
Americans buy about 5 billion over-the-counter drugs each year, according to government estimates, to treat their headaches, heartburn, coughs and colds, and other routine health problems. According to the Consumer Healthcare Products Association, a trade

 


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Drug Litigation Terms

 


Today's Terms

Therapeutic Equivalence (TE)

Definition:
Drug products classified as therapeutically equivalent can be substituted with the full expectation that the substituted product will produce the same clinical effect and safety profile as the prescribed product.

Brand Name Drug

Definition:
A brand name drug is a drug marketed under a proprietary, trademark-protected name.

Active Ingredient

Definition:
An active ingredient is any component that provides pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or animals.

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Drug Litigation Hot Topics

 


Topics Related to Drug Litigation:

  • Adverse Effects
  • Prescription Drugs
  • Over the Counter Drugs
  • Drug Recalls
  • Dosage Errors
  • Drug Company Liability
  • Drug Company Negligence
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